Promonitor®-IFX Ref. 506XX30000

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Quantitative measure of infliximab.

Promonitor®-IFX is an enzyme-linked immunosorbent assay (ELISA) for the quantitative determination of infliximab (IFX, Remicade®) in human serum samples. The amount of IFX, when considered in conjunction with anti-IFX antibodies (Promonitor®-anti-IFX Ref. 5070230000) and clinical findings, like disease activity, contributes valuable information to the physician to assess the efficacy of therapies with IFX, predict infusion-related reactions and loss of clinical response by the patient. The correlation between reduced serum IFX concentrations, anti-IFX antibody formation, and increased disease activity has been demonstrated in several clinical studies in a series of pathologies.

Promonitor®-IFX is a capture ELISA where microwell strips are provided pre-coated with an anti-TNFa human F(ab´)2 fragment bound to human recombinant TNFa. Diluted calibrators, controls and diluted patient samples are added to separate wells, allowing IFX present to bind to pre-immobilized TNFa. Unbound sample is washed away, and the specific HRP-labeled anti-IFX monoclonal antibody is added to each well. A second incubation step allows the anti-IFX antibody to bind to the IFX that has become attached to the microwells. After washing away the excess of unbound HRP-labeled anti-IFX antibody, the remaining enzyme activity is measured by adding a chromogenic substrate and measuring the intensity of the color that develops in a spectrophotometer. The signal obtained is proportional to the amount of IFX in the patient sample.

Optical densities (OD) of the calibrators are plotted to construct the IFX calibration curve. A four parameter logistic (4PL) model is used to fit the curve. Positive and Negative Controls are used to monitor assay performance. IFX concentration is calculated by interpolating sample OD in the calibration curve. Therapeutical interpretation of IFX results in a clinical setting is provided. Warnings for each sample are optionally included; this setting can be configured here.

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